Why it is prescribed :
This combination medication contains renin inhibitor and calcium channel blocker, prescribed for high blood pressure.
Amlodipine relaxes (widens) blood vessels where as Aliskiren inhibits renin and increase the blood flow.
When it is not to be taken (Contraindications):
Contraindicated in patients with diabetes, and hypersensitivity.
Do not use aliskiren with angiotensin receptor blockers (ARBs) and the angiotensin converting enzyme inhibitors (ACEIs)in patients with diabetes.
Category D :
There is an evidence of fetal risk based on adverse reaction data, but potential benefits may allow the drug to be used in pregnant women despite risks.
Dosage & When it is to be taken (Indications):
The recommended initial once-daily dose is 150mg/5 mg. Titrate as needed to a maximum of 300-mg/10 mg.
How it should be taken :
It comes as a tablet to take by mouth, with or without food.
Warnings and Precautions :
Caution should be exercised in patients with history of angioedema, dehydration, low blood volume, high blood potassium, low-salt (sodium) diet, gout, heart, liver or kidney disease, low blood pressure, blood vessel problems, diabetes, any allergy, who are taking other medications, elderly, children, during pregnancy and breastfeeding.
It may cause dizziness, lightheadedness, or fainting, do not drive a car or operate machinery and get up slowly from bed while taking this medication.
It may cause a serious side effect called angioedema, with the following symptoms: swelling of the hands, face, lips, eyes, throat, or tongue; difficulty in swallowing or breathing or hoarseness. If it is so consult with your healthcare provider.
Monitor blood pressure, kidney function, and blood electrolyte levels.
Side Effects :
Diarrhea, abdominal pain, indigestion, and gastroesophageal reflux.
Abnormal heart rhythm, slow heart rate, chest pain, fainting, low blood pressure, inflammation of blood vessels.
Central Nervous System
Sensory loss, tingling, tremor, sexual dysfunction, sleeplessness, nervousness, depression, abnormal dreams, anxiety, and depersonalization.
Loss of appetite, constipation, difficulty in swallowing, flatulence, inflammation of pancreas, vomiting, gum swelling.
Allergic reaction, weakness, back pain, hot flushes, uneasiness, pain, rigors, weight gain, weight decrease.
Joint pain, muscle pain, degenerative disease of a joint, muscle cramps.
Difficulty in breathing, nosebleed.
Angioedema, itching, rash.
Other Precautions :
Avoid excess dosage.
Storage Conditions :
Store at 25°C. Protect from heat and moisture.
♦ Safety Labeling Changes Approved By FDA